CataractNCT04924231
Effect of 1.8-mm Steep-axis Clear Corneal Incision on the Posterior Corneal Astigmatism in Candidates for Toric IOL Implantation
An observational study of Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
we aimed to analyze the effects of cataract surgery using a 1.8-mm steep-axis clear corneal incision (CCI) on the posterior corneal surfaces based on the keratometry from the rotating Scheimpflug imaging device (Pentacam HR) in candidates for toric intraocular lens (IOL) implantation Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- astigmatism
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2017to 1 May 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients, who underwent cataract surgery with a 1.8-mm steep-axis CCI at the Eye Center, the Second Affiliated Hospital of Zhejiang University
Who may be able to join
- patients aged at least 45 years old who were scheduled for cataract surgery; (2) regular corneal astigmatism ≥ 1.0 D; (3) the imaging quality parameter (QS) of Pentacam HR was "OK"; and (4) follow-up time ≥1.0 month.
- Exclusion Criteria:(1) irregular corneal astigmatism; (2) corneal scar, corneal degeneration, pterygium invading the optic zone; (3) corneal endothelium count<1,000/mm2, corneal endothelial dystrophy, iritis, glaucoma and retinal disease; (4) history of eye surgery, such as corneal refractive surgery, corneal transplantation and retinal surgery; (5) the main incision was expanded or sutures were used during surgery; and (6) some postoperative complications, such as persistent corneal edema, Descemet's membrane detachment and poor wound healing, and any others that might affect the measurement results of the Pentacam HR during the follow-up period.
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
About this study
we aimed to analyze the effects of cataract surgery using a 1.8-mm steep-axis clear corneal incision (CCI) on the posterior corneal surfaces based on the keratometry from the rotating Scheimpflug imaging device (Pentacam HR) in candidates for toric intraocular lens (IOL) implantation
Read the detailed description
Preoperative and at least 1-month postoperative data measured by Pentacam HR were collected in patients for toric IOL implantation. Surgically induced astigmatism on the posterior cornea (P-SIA) was calculated based on the preoperative and postoperative keratometric data, and the related factors of P-SIA were analyzed.
- Conditions
- Cataract
- Being tested
- astigmatism
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
astigmatismBehavioural
astigamatism at least 1 month after the cataract surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal astigmatism
postoperative anterior, posterior and total corneal astigmatism
Measured: post 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2021
- Study start1 Feb 2017
- Primary completion30 Mar 2018
- Study completion1 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924231
- Sponsor's protocol ID
- 2020-407
- Status last verified
- Jun 2021
- First submitted
- 8 Jun 2021
- Last updated
- 11 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of 1.8-mm Steep-axis Clear Corneal Incision on the Posterior Corneal Astigmatism in Candidates for Toric IOL Implantation
- ClinicalTrials.gov ID
- NCT04924231
- Acronym / sponsor ID
- 2020-407
- Conditions
- Cataract
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 1 May 2018 (actual)
- First posted
- 11 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
we aimed to analyze the effects of cataract surgery using a 1.8-mm steep-axis clear corneal incision (CCI) on the posterior corneal surfaces based on the keratometry from the rotating Scheimpflug imaging device (Pentacam HR) in candidates for toric intraocular lens (IOL) implantation
Detailed description
Preoperative and at least 1-month postoperative data measured by Pentacam HR were collected in patients for toric IOL implantation. Surgically induced astigmatism on the posterior cornea (P-SIA) was calculated based on the preoperative and postoperative keratometric data, and the related factors of P-SIA were analyzed.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients, who underwent cataract surgery with a 1.8-mm steep-axis CCI at the Eye Center, the Second Affiliated Hospital of Zhejiang University
Key inclusion criteria (3 listed)
- patients aged at least 45 years old who were scheduled for cataract surgery; (2) regular corneal astigmatism ≥ 1.0 D; (3) the imaging quality parameter (QS) of Pentacam HR was "OK"; and (4) follow-up time ≥1.0 month.
- Exclusion Criteria:(1) irregular corneal astigmatism; (2) corneal scar, corneal degeneration, pterygium invading the optic zone; (3) corneal endothelium count<1,000/mm2, corneal endothelial dystrophy, iritis, glaucoma and retinal disease; (4) history of eye surgery, such as corneal refractive surgery, corneal transplantation and retinal surgery; (5) the main incision was expanded or sutures were used during surgery; and (6) some postoperative complications, such as persistent corneal edema, Descemet's membrane detachment and poor wound healing, and any others that might affect the measurement results of the Pentacam HR during the follow-up period.
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| astigmatismastigamatism at least 1 month after the cataract surgery | Behavioural | – |
Primary outcome
corneal astigmatism
Time frame: post 1 month
postoperative anterior, posterior and total corneal astigmatism
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal astigmatism (time frame: post 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2021.